| Reference Listed Drug | NDA Holder | Generic Drug Name | ANDA Applicant(s) |
Indication | Launch Date |
|---|---|---|---|---|---|
| Exforge | Novartis | Amlodipine / Valsartan | Lupin Pharmaceuticals | treatment of hypertension and to lower blood pressure | 4/1/2015 |
| FemHRT | Warner Chilcott | Norethindrone Acetate / Ethinyl Estradiol | Glenmark Generics | moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis | 4/7/2015 |
| Generess Fe Tablets | Warner Chilcott | Norethindrone / Ethinyl Estradiol / Ferrous Fumarate | Mylan | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 4/7/2015 |
| Exalgo | Mallinckrodt | Hydromorphone Extended-Release Tablets | Perrigo | treatment of chronic pain in opioid-tolerant patients requiring continuous around-the-clock opioid analgesia for an extended amount of time | 4/8/2015 |
| Lybrel | Wyeth | Levonorgestrel / Ethinyl Estradiol Tablets USP | Glenmark Generics | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 4/10/2015 |
| Kenalog Topical Spray | Sun Pharma | Triamcinolone Acetonide Topical Aerosol | Perrigo | relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses | 4/16/2015 |
| Abilify | Otsuka Pharmaceutical | Aripiprazole | Teva Pharmaceutical Industries | treatment of schizophrenia and for the acute treatment of manic and mixed episodes associated with bipolar I disorder | 4/28/2015 |
| Seasonale | Teva Women's Health | Levonorgestrel / Ethinyl Estradiol Tablets | Mylan | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 5/5/2015 |
| Pulmicort Respules | AstraZeneca | Budesonide Inhalation Suspension | Allergan | maintenance medicine to control and prevent asthma symptoms in children ages 12 months to 8 years | 5/7/2015 |
| Lotronex | Prometheus Laboratories | Alosetron Hydrochloride Tablets | Roxane Laboratories | for some women with severe Irritable Bowel Syndrome (IBS) | 5/21/2015 |
| DDAVP | Ferring Pharmaceuticals | Desmopressin Acetate Tablets | Glenmark Pharmaceuticals | antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of temporary polyuria and polydipsia following head trauma or surgery in the pituitary region | 5/29/2015 |
| Lomedia 24 Fe | Amneal | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | Teva | for prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 5/29/2015 |
| Actonel | Actavis | Risedronate Sodium Tablets | Teva | help increase bone mass and help reduce the chance of having a spinal or non-spinal fracture (break) and are also used to treat or prevent osteoporosis in either men or women who are taking corticosteroid medicines, and to treat Paget's disease of the bone | 6/1/2015 |
| Intuniv | Shire | Guanfacine Hydrochloride Extended-Release Tablets | Mylan | treatment of Attention Deficit Hyperactivity Disorder (ADHD) | 6/2/2015 |
| Seasonique | Teva | Levonorgestrel / Ethinyl Estradiol Tablets | Mylan (Famy Care) | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 6/2/2015 |
| Intuniv | Shire | Guanfacine Hydrochloride Extended-Release Tablets | Teva | treatment of Attention Deficit Hyperactivity Disorder (ADHD) | 6/2/2015 |
| Intuniv | Shire | Guanfacine Hydrochloride Extended-Release Tablets | Sandoz | treatment of Attention Deficit Hyperactivity Disorder (ADHD) | 6/4/2015 |
| Dovonex Cream | Leo Pharma | Calcipotriene Cream | Glenmark Pharmaceuticals | treatment for psoriasis | 6/11/2015 |
| Seasonale | Teva Women's Health | Levonorgestrel / Ethinyl Estradiol Tablets | Glenmark Pharmaceuticals | prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception | 6/15/2015 |
| Copaxone | Teva | Glatiramer Acetate | Sandoz | treatment for relapsing forms of Multiple Sclerosis | 6/18/2015 |
